Interview conducted by April Cashin-Garbutt, BA Hons (Cantab)
It has recently been reported that BioDiem plans to create new “non-influenza” vaccines. Please could you tell us more about this? What types of vaccine are you planning on creating?
We recently signed a collaborative agreement with The Royal Melbourne Institute of Technology (RMIT) for the development of non-influenza vaccines using BioDiem’s proprietary live attenuated influenza virus (LAIV) technology.
While we currently receive royalties from the outlicensing of the LAIV technology for the creation of influenza vaccines, it has potential for developing both therapeutic and preventative vaccines. Our strategy in this area is to complement our influenza portfolio with therapies and vaccines for other infectious diseases.
For example, while we have several potential targets in mind, our research partnerships may lead to vaccines against cancers such as nasopharyngeal carcinoma (a cancer of the upper airways) which is strongly linked to infection with the Epstein-Barr virus. This is a particularly prevalent cancer in Asia, and the theory behind this is that if you vaccinate against Epstein-Barr, you are also effectively boosting immunity to help clear the cancer.
Your new vaccines will be based on the technology used in your live attenuated influenza virus (LAIV) vaccine. Please could you tell us a little bit about the mechanism of this vaccine?
BioDiem’s LAIV vaccine was originally in-licensed in 1998 from the Institute of Experimental Medicine (IEM) in St Petersburg, Russia. The LAIV technology has been used for the development of the LAIV vaccine, an intranasal vaccine which has been launched in India under the trade name Nasovac to combat influenza and has been used in Russia for many years..
They are made by “reassorting” BioDiem’s Master Donor Strains with those “wild type” viruses as recommended annually by the World Health Organization (as flu viruses typically mutate and change seasonally) and then selecting the reassortants that will trigger the body’s defences again the wild-type flu and with the right safety profile. The intranasal vaccine triggers a rapid immune response in the mucosal lining of nose and the pharynx and systemically in the blood.
LAIV vaccines are distinctive for a number of advantages including the capacity to produce more doses when cultivated in eggs (the most common growth medium for vaccine manufacture) and the possibility of rapid manufacture over 3-4 weeks using cell-based production instead of the typical 8 weeks required for conventional influenza vaccines. These advantages of increased dosage, non reliance on egg supply and quicker turnaround times are essential in the face of a pandemic.
How are you going to adjust this mechanism to provide a vaccine for other diseases?
BioDiem intends to reengineer new versions of the LAIV vaccines using the original master donor strains coupled with antigens (proteins which stimulate an immune response) specific to the targeted infectious disease in question. We are working with RMIT and a French partner, VIVALIS, to explore different ways in which we can achieve this goal.
How difficult do you think this project will be, and how long do you think it will take?
It’s difficult to place exact timeframes on developmental projects, but given that the LAIV vaccine is extremely well characterised after decades of study and use, we are confident that the research teams at both Vivalis in France, and in the RMIT Biotechnology Laboratory headed up by Professor Peter Smooker and Dr Hao Van will do excellent work and thoroughly explore the opportunity with this technology. That said, any research project takes place in stages, and we envision being able to provide significant updates on research progress within 12 months.
What are the main obstacles that will need to be overcome in order to use the LAIV technology to create other vaccines?
As with any project we expect technical hurdles which will need to be addressed however beyond this the speed to commercialisation excites us because of the existing data and understanding we already have about the LAIV use and clinical trials from work done in influenza. The combination of high quality materials and safety profile data position us very favourably for accelerating into a clinical program
Many people often worry over the safety of vaccines. How are you going to test your vaccines to make sure that they are safe?
The most important goal for BioDiem at this stage is delivering proof-of-concept of the adaptation of the LAIV for other vaccine types. This will involve preclinical work and the generation of significant data. This milestone will be a major achievement for us. The next step would be proceeding through rigorous clinical trials with patients as prescribed by regulatory authorities, however as mentioned above, we already have a long history of use of the LAIV on the market in Russia and more recently in India and so have a well-characterised safety profile for the technology in influenza prevention.
How do you see the future of vaccinations progressing?
Millions of lives are claimed globally every year because of infectious diseases that have no effective vaccine. Poor availability of medicines and effective preventative measures lead to particularly high rates of infectious disease in developing countries.
Progress in understanding how the immune system works will lead to new and better vaccines. For example, HIV, malaria and tuberculosis are the biggest infectious diseases killers and effective preventative vaccines for these are lacking. There is also a real need for innovative methods of vaccine delivery such as intranasal delivery to make administration easier and improve the immune response. For example, BioDiem’s LAIV vaccine is delivered intranasally which reduces anxiety around injections especially in children and also reduces the need for medical or healthcare professionals in understaffed settings.
What are BioDiem’s plans for the future?
BioDiem’s vision is to become a provider of solutions globally for infectious disease and related cancers. In the near term, we plan to expand our existing revenue stream from the LAIV influenza vaccine business with potential partners reached via our partnership with the WHO. This partnership provides us access for the outlicensing of our LAIV technology for influenza vaccines to the developing world. We currently partner with the Serum Institute in India, one of the world’s largest vaccine makers and BCHT Changchun Biotechnology in China, a well established Chinese biopharmaceutical company.
BioDiem intends to progress its pipeline for non-influenza vaccines. We are currently seeking to accelerate development of our antimicrobial drug, BDM-I , against a range of infectious diseases ranging from “neglected” parasitic diseases of the developing world such as schistosomiasis to antibiotic resistant “superbugs” such as methicillin resistant Staphylococcus aureus (MRSA). MRSA infections are a major issue in the developed world because they can spread rapidly causing serious and sometimes fatal infections, and are increasingly difficult to treat, so this is a priority area for developers of new antibiotic products.
We are also working concurrently with our partners (including the University of Canberra, Australian National University and RMIT) to progress vaccine technologies which may target hepatitis, dengue fever and NPC, while looking forward to potential out-licensing opportunities for our eye disease drug, BDM-E. BDM-E has a strong profile of supportive preclinical evidence in its favour in the treatment of retinitis pigmentosa, but in line with our focus on infectious diseases we are moving to divest BioDiem of this asset.
In short we see BioDiem moving forward as a nimble player in the space of infectious disease therapy and vaccine development, with a strong partnering network giving us options for both niche high-value treatments as well as large-market opportunities.
Would you like to make any further comments?
I’ll take the opportunity to give you an overview of BioDiem’s recent activity starting with the out-licensing of our LAIV technology to international partners, the Serum Institute in India in 2011 and BCHT Changchun in China in February 2012. In May, we received extra patent protection around the use of our exciting antimicrobial drug BDM-I in major indications. We also received license fees in May of $US0.844 million.
Subsequently, BioDiem has embarked on a journey for collaborative agreements starting with the partnering with French-based VIVALIS to expand its vaccine production technologies, followed by a partnership with US advocacy group Foundation Fighting Blindness to expand testing of BDM-E’s effectiveness in retinitis pigmentosa at the end of May. BioDiem has just presented its positive findings on BDM-E at an international conference which we believe enhances its out-licensing opportunities.
BioDiem has also in-licensed technologies from the Australian National University and subsequently the University of Canberra for novel vaccine technologies addressing dengue fever and hepatitis respectively as lead indications. Most recently, we partnered with RMIT University for collaborative research on the development of non-influenza vaccines.
Where can readers find more information?
About Julie Phillips, Executive Director & Chief Executive Officer of BioDiem
Ms Phillips was appointed to the position of Chief Executive Office on July 1, 2009 and was appointed a director on May 7, 2010. She has a strong background in the biotech and pharmaceutical industry, having worked as the CEO and director of start-up Australian biotechnology companies operating in the life sciences sector.
Her technical background in clinical trials, regulatory affairs and pharmaco-economic assessment/pricing of therapeutics was gained in multinational pharmaceutical companies with responsibility for market entry of new products in Australia and New Zealand. Ms Phillips is also on the Board of the CRC for Asthma and Airways Ltd.